Sensitivity and Specificity of the Alvarado Score for the Timely Differential Diagnosis of Acute Appendicitis in Samoa

December 7, 2021 updated by: Dr Annette Kaspar
Retrospective clinical data review design of all patients admitted to the Tupua Tamasese Meaole Hospital Surgical Unit for AA from January 2015 to December 2016. Exclusion criteria were appendiceal abscess and/or mass, and final diagnosis 'not acute appendicitis'. Age, sex, village, Alvarado Score, Ultrasound Scan Result, surgical management, and histopathology result were the main variables entered into the SPSS statistical software package for analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

METHODS

Study Design and Data Collection

A retrospective study design was used to evaluate all AA cases seen by the Surgical Department of TTM Hospital over the 24-month period between 1 January 2015 and 31 December 2016. The clinical medical records were obtained from the National Health Service PATIS System, using the search terms 'appendicitis', 'acute appendicitis', and 'appendicectomy'. A total of 289 records were retrieved. Thirty four (34) records were excluded having met the exclusion criteria: (1) final diagnosis was not AA (i.e., ectopic pregnancy, tubal ovarian abscess, other gynaecological pathologies, diverticulitis, Merkel diverticulitis, perforated ulcer), and (2) appendiceal abscess and/or appendiceal mass. Thirty (30) clinical records with missing data, and these were also excluded from the study. The final number of included for analysis was 225 cases. All 225 cases were initially treated with intravenous antibiotics upon presentation to the emergency department as per the National Health Service antibiotic guidelines: intravenous ceftriaxone and metronidazole was the first line of treatment, and alternative antibiotics were administered if unavailable (i.e., clindamycin + gentamycin or ampicillin, or gentamycin + metronidazole).

A purpose-designed data collection form and excel spreadsheet were created for the study. The following information was extracted from the clinical records: patient gender (male/female), age (years), address (urban/rural), time of admission (Morning/Afternoon/Night Shift), use of traditional/alternative medicine prior to attending emergency department (yes/no), administration of antibiotics by emergency department staff (yes/no), Alvarado Score (1-10), Ultrasound Scan for AA (Positive/negative/Inconclusive/Not performed), management of AA (appendicectomy/antibiotic therapy), intra-operative macroscopic examination (Grade 1-5), histopathology result for AA (Positive/Negative/Inconclusive/Not available), length of stay in hospital (days), and mortality (yes/no).

Data analysis The data was analysed using the SPSS (Version 2.1) statistical software package. Descriptive analysis was performed, and the chi-square test of significance was used to investigate for statistically significant differences between variables (significant at p<0.05). The sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) were calculated for the Alvarado Score in identifying AA as confirmed by histopathology.

Study Type

Observational

Enrollment (Actual)

225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Acute Appendicitis cases seen by the Surgical Department of TTM Hospital over the 24-month period between 1 January 2015 and 31 December 2016.

The final number of included for analysis was 225 cases.

Description

Inclusion Criteria:

• All Acute Appendicitis (AA) cases seen by the Surgical Department of TTM Hospital over the 24-month period between 1 January 2015 and 31 December 2016.

Exclusion Criteria:

  • Final diagnosis was not Acute Appendicitis (i.e., ectopic pregnancy, tubal ovarian abscess, other gynaecological pathologies, diverticulitis, Merkel diverticulitis, perforated ulcer)
  • Final diagnosis was appendiceal abscess and/or appendiceal mass.
  • Clinical records with missing data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of the Alvarado Score for the identification of acute appendicitis in Samoa
Time Frame: 24 months
The sensitivity of the Alvarado Score will be calculated for correct diagnosis of acute appendicitis based on confirmed acute appendicitis by histopathology results
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the Alvarado Score for the identification of acute appendicitis in Samoa
Time Frame: 24 months
The specificity of the Alvarado Score will be calculated for correct diagnosis of acute appendicitis based on confirmed cases of acute appendicitis by histopathology
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 14, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 23, 2021

Study Record Updates

Last Update Posted (Actual)

December 23, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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